Acute PainNCT03048214
Effect of Nerve Block Versus General Anaesthesia for Distal Radial Fracture Surgery
A study testing Infraclavicular nerve block and General anaesthesia in people with Acute Pain, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study aims to investigate whether infraclavicular nerve block improves acute postoperative pain after distal radial fracture surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- Infraclavicular nerve block and General anaesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteHong Kong
- Study dates
- 16 May 2017to 14 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III
- Age 18-80 years old
- Scheduled for distal radial fracture surgery (ie open reduction and internal fixation)
Who cannot join
- Surgery involving more than distal radial fracture of the affected arm
- Known allergy to opioids (including the weak opioids tramadol and dihydrocodeine), local anaesthetic drugs, non-steroidal anti-inflammatory drugs (NSAIDS) including COX-2 inhibitors, paracetamol.
- History of chronic pain
- Alcohol or drug abuse
- Impaired renal function, defined as preoperative serum creatinine level over 120 µmol/L
- Patients with liver dysfunction (Plasma bilirubin over 34 mol/L, INR >/=1.7, ALT and AST over 100U/L)
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- Pre-existing neurological or muscular disorders
- Psychiatric illness
- Impaired or retarded mental state
- Not self-ambulatory before operation
- Pregnancy
- Local infection
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Infraclavicular Nerve Block Versus General Anaesthesia for Acute Postoperative Pain After Distal Radial Fracture Surgery
This study aims to investigate whether infraclavicular nerve block improves acute postoperative pain after distal radial fracture surgery.
Read the detailed description
A single blinded randomized control trial will be performed to compare regional anaesthesia with single shot infraclavicular nerve block versus general anaesthesia.
The primary outcome was postoperative NRS pain score (0-10) with movement at 24 hours after surgery. No suitable references for postoperative NRS pain scores at 24 hours that could be used for sample size calculation was found. Based on a previous study on RA versus GA for hand surgery, the standard deviation estimate of the treatments for sample size calculation was 2.86. To detect a difference in NRS pain score of 2.4/10 at a significance level of 0.05 and a power of 0.80, the minimum number of patients required per group was 23. A difference of 2.4 in NRS pain score was chosen because this has been shown to correspond to 'much improvement' in pain relief, which is clinically significant. To take into account for possible dropouts, 26 patients were recruited into each group.
Patients will be approached in the general ward before operation. The aims of the study and need for follow up assessment would be explained and patient will be recruited only if s/he agrees. After agreeing to join the study, patients will be randomly allocated to one of two groups: 1) General anaesthesia (GA) 2) Regional Anaesthesia with infraclavicular block (RA). Outcomes of patients in receiving general anaesthesia (GA) will be compared with patients receiving infraclavicular nerve block (RA).
Data Analysis Intention-to-treat will be used. Patients will remain in their initial designated groups for data analysis even if there is a change in surgical or anaesthetic/analgesic management, as long as they are undergoing distal radial fracture surgery not involving another operative site (eg bone graft). Patients in the RA group who required conversion to general anaesthesia due to inadequate infraclavicular block would remain in the RA group for data analysis.
Statistical methods used:
- Incidence of chronic post surgical pain: Chi-Square test
- NRS pain scores at 3 and 6 months after surgery: Mann-Whitney test to look at difference in mean pain scores between two groups
- duration of anaesthetic, analgesic and surgical procedures, time to extubation, cumulative opioid consumption, dose and frequency of rescue analgesic used, time to food intake and ambulation, time to discharge, patient satisfaction: Kruskal-Wallis test
- Acute NRS pain scores over 48 hours: Postoperative NRS pain scores were expressed in median (interquartile range) and analyzed using Mann-Whitney U test with post-hoc multiple comparisons using Bonferroni procedure
- Patient demographic data: One way ANOVA and chi-square test.
- Intraoperative vital signs, HRQOL, HADS, DASH-HKPWH: Repeated measures ANOVA (with Bonferroni correction when appropriate)
- Side effects and postoperative complications: Chi Square test
- When a significant result is obtained, t-test or Mann-Whitney test for numerical values and Chi-square test for categorical data will be applied for post hoc pairwise comparisons.
- Conditions
- Acute Pain
- Being tested
- Infraclavicular nerve block, General anaesthesia
- Keywords
- Nerve block; Infraclavicular; Acute pain
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infraclavicular nerve blockProcedure or surgery
Infraclavicular nerve block is a relatively safe and straightforward brachial plexus nerve block that can be used to provide intraoperative regional anaesthesia for upper limb surgeries from the elbow to fingers.
General anaesthesiaProcedure or surgery
Usual practice for upper limb surgeries.
| Study group | Role | What they receive |
|---|---|---|
| General Anaesthesia | Sham comparator | Patients would receive routine general anaesthesia for their distal radial fracture surgery Receives: Procedure: General anaesthesia |
| Regional Anaesthesia | Experimental | Patients would receive routine infraclavicular nerve block for their distal radial fracture surgery Receives: Procedure: Infraclavicular nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute postoperative pain score
pain score would be recorded on postoperative day 1 using numeral rating scale
Measured: At postoperative day 1
Secondary outcomes (2)
Chronic pain score
chronic pain score would be recorded on postoperative 3rd month using numeral rating scale
Measured: At postoperative 3rd month
Analgesic drug consumption
Total analgesic drug consumption would be recorded on discharge day base on drug record from patient record
Measured: On discharge day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start16 May 2017
- Primary completion13 Jul 2018
- Study completion14 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wong Sau Ching Stanley, The University of Hong Kong
- Investigators
- Stanley SC Wong, MBBS, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048214
- Sponsor's protocol ID
- UW16-005
- Status last verified
- Mar 2019
- First submitted
- 23 Jan 2017
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McCartney CJ, Brull R, Chan VW, Katz J, Abbas S, Graham B, Nova H, Rawson R, Anastakis DJ, von Schroeder H. Early but no long-term benefit of regional compared with general anesthesia for ambulatory hand surgery. Anesthesiology. 2004 Aug;101(2):461-7. doi: 10.1097/00000542-200408000-00028.
PubMed 15277930Cepeda MS, Africano JM, Polo R, Alcala R, Carr DB. What decline in pain intensity is meaningful to patients with acute pain? Pain. 2003 Sep;105(1-2):151-7. doi: 10.1016/s0304-3959(03)00176-3.
PubMed 14499431Wong SS, Chan WS, Fang C, Chan CW, Lau TW, Leung F, Cheung CW. Infraclavicular nerve block reduces postoperative pain after distal radial fracture fixation: a randomized controlled trial. BMC Anesthesiol. 2020 May 28;20(1):130. doi: 10.1186/s12871-020-01044-4.
PubMed 32466746
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Infraclavicular Nerve Block Versus General Anaesthesia for Acute Postoperative Pain After Distal Radial Fracture Surgery
- ClinicalTrials.gov ID
- NCT03048214
- Acronym / sponsor ID
- UW16-005
- Conditions
- Acute Pain
- Keywords
- Nerve block; Infraclavicular; Acute pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 16 May 2017 (actual)
- Primary completion
- 13 Jul 2018 (actual)
- Study completion
- 14 Dec 2018 (actual)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate whether infraclavicular nerve block improves acute postoperative pain after distal radial fracture surgery.
Detailed description
A single blinded randomized control trial will be performed to compare regional anaesthesia with single shot infraclavicular nerve block versus general anaesthesia.
The primary outcome was postoperative NRS pain score (0-10) with movement at 24 hours after surgery. No suitable references for postoperative NRS pain scores at 24 hours that could be used for sample size calculation was found. Based on a previous study on RA versus GA for hand surgery, the standard deviation estimate of the treatments for sample size calculation was 2.86. To detect a difference in NRS pain score of 2.4/10 at a significance level of 0.05 and a power of 0.80, the minimum number of patients required per group was 23. A difference of 2.4 in NRS pain score was chosen because this has been shown to correspond to 'much improvement' in pain relief, which is clinically significant. To take into account for possible dropouts, 26 patients were recruited into each group.
Patients will be approached in the general ward before operation. The aims of the study and need for follow up assessment would be explained and patient will be recruited only if s/he agrees. After agreeing to join the study, patients will be randomly allocated to one of two groups: 1) General anaesthesia (GA) 2) Regional Anaesthesia with infraclavicular block (RA). Outcomes of patients in receiving general anaesthesia (GA) will be compared with patients receiving infraclavicular nerve block (RA).
Data Analysis Intention-to-treat will be used. Patients will remain in their initial designated groups for data analysis even if there is a change in surgical or anaesthetic/analgesic management, as long as they are undergoing distal radial fracture surgery not involving another operative site (eg bone graft). Patients in the RA group who required conversion to general anaesthesia due to inadequate infraclavicular block would remain in the RA group for data analysis.
Statistical methods used:
- Incidence of chronic post surgical pain: Chi-Square test
- NRS pain scores at 3 and 6 months after surgery: Mann-Whitney test to look at difference in mean pain scores between two groups
- duration of anaesthetic, analgesic and surgical procedures, time to extubation, cumulative opioid consumption, dose and frequency of rescue analgesic used, time to food intake and ambulation, time to discharge, patient satisfaction: Kruskal-Wallis test
- Acute NRS pain scores over 48 hours: Postoperative NRS pain scores were expressed in median (interquartile range) and analyzed using Mann-Whitney U test with post-hoc multiple comparisons using Bonferroni procedure
- Patient demographic data: One way ANOVA and chi-square test.
- Intraoperative vital signs, HRQOL, HADS, DASH-HKPWH: Repeated measures ANOVA (with Bonferroni correction when appropriate)
- Side effects and postoperative complications: Chi Square test
- When a significant result is obtained, t-test or Mann-Whitney test for numerical values and Chi-square test for categorical data will be applied for post hoc pairwise comparisons.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anaesthesia | Sham comparator | Procedure: General anaesthesiaPatients would receive routine general anaesthesia for their distal radial fracture surgery |
| Regional Anaesthesia | Experimental | Procedure: Infraclavicular nerve blockPatients would receive routine infraclavicular nerve block for their distal radial fracture surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-III
- Age 18-80 years old
- Scheduled for distal radial fracture surgery (ie open reduction and internal fixation)
Key exclusion criteria (13 listed)
- Surgery involving more than distal radial fracture of the affected arm
- Known allergy to opioids (including the weak opioids tramadol and dihydrocodeine), local anaesthetic drugs, non-steroidal anti-inflammatory drugs (NSAIDS) including COX-2 inhibitors, paracetamol.
- History of chronic pain
- Alcohol or drug abuse
- Impaired renal function, defined as preoperative serum creatinine level over 120 µmol/L
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infraclavicular nerve blockInfraclavicular nerve block is a relatively safe and straightforward brachial plexus nerve block that can be used to provide intraoperative regional anaesthesia for upper limb surgeries from the elbow to fingers. | Procedure or surgery | Regional Anaesthesia |
| General anaesthesiaUsual practice for upper limb surgeries. | Procedure or surgery | General Anaesthesia |
Primary outcome
Acute postoperative pain score
Time frame: At postoperative day 1
pain score would be recorded on postoperative day 1 using numeral rating scale
2 secondary outcomes
Chronic pain score
Time frame: At postoperative 3rd month
Analgesic drug consumption
Time frame: On discharge day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
- Background: PubMed 15277930McCartney CJ, Brull R, Chan VW, Katz J, Abbas S, Graham B, Nova H, Rawson R, Anastakis DJ, von Schroeder H. Early but no long-term benefit of regional compared with general anesthesia for ambulatory hand surgery. Anesthesiology. 2004 Aug;101(2):461-7. doi: 10.1097/00000542-200408000-00028.
- Background: PubMed 14499431Cepeda MS, Africano JM, Polo R, Alcala R, Carr DB. What decline in pain intensity is meaningful to patients with acute pain? Pain. 2003 Sep;105(1-2):151-7. doi: 10.1016/s0304-3959(03)00176-3.
- Derived from this study: PubMed 32466746Wong SS, Chan WS, Fang C, Chan CW, Lau TW, Leung F, Cheung CW. Infraclavicular nerve block reduces postoperative pain after distal radial fracture fixation: a randomized controlled trial. BMC Anesthesiol. 2020 May 28;20(1):130. doi: 10.1186/s12871-020-01044-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanley SC Wong, MBBS principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infraclavicular nerve block and General anaesthesia in people with Acute Pain, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute postoperative pain score (time frame: At postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03048214, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2019.